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Abstract Details

Efficacy of Fremanezumab in Patients With Moderate and Higher Frequency Episodic Migraine
Headache
Headache Posters (7:00 AM-5:00 PM)
046

Patients with higher-frequency EM (HFEM; 10-14 migraine days/month) may experience greater disease burden and different treatment response than those with lower-frequency EM. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets the calcitonin gene-related peptide (CGRP), has proven efficacy for migraine preventive treatment. This pooled analysis evaluated the efficacy of fremanezumab in patients with HFEM and moderate-frequency EM (MFEM; 4-9 days/month).

This pooled analysis of fremanezumab clinical trial data evaluated efficacy outcomes in patients with episodic migraine (EM) by category of baseline migraine frequency.

This analysis included patients with EM from 2 double-blind phase 3 trials (HALO EM and FOCUS [patients with inadequate response to 2-4 prior preventive treatment classes]). Patients were randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or placebo for 12 weeks. Changes in monthly average migraine days (MMDs) and headache days of at least moderate severity (MHDs) and proportions of patients with ≥50% reduction in MMD were evaluated in patients with MFEM and HFEM at baseline.

Among 1,174 participants, 659 had MFEM and 515 had HFEM at baseline. Least-squares mean(SE) reductions from baseline in MMDs over 12 weeks were significantly greater with fremanezumab versus placebo in the MFEM group (quarterly, −3.5[0.22]; monthly, −3.4[0.22] vs placebo, −1.5[0.21]) and HFEM group (quarterly, −4.2[0.35]; monthly, −4.7[0.35] vs placebo, −2.8[0.35]; all P≤0.0009), as were reductions in MHDs (MFEM: quarterly, −3.0[0.19]; monthly, −2.8[0.19] vs placebo, −0.8[0.18]; HFEM: quarterly, −3.5[0.31]; monthly, −3.7[0.31] vs placebo, −1.8[0.30]; all P<0.0001). Proportions of patients with ≥50% reduction in MMDs were also significantly higher with fremanezumab versus placebo in both groups (MFEM: quarterly, 51%; monthly, 50% vs placebo, 25%; HFEM: quarterly, 38%; monthly, 42% vs placebo, 21%; all P≤0.0005).

Fremanezumab demonstrated efficacy, based on reductions in MMDs and MHDs versus placebo, with similar therapeutic gains in the MFEM and HFEM groups.

Authors/Disclosures
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University)
PRESENTER
Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tonix. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Learning Network. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert/talent for CME event with Medscape/WebMD.
Xiaoping Ning (Teva pharmaceuticals) Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
Joshua M. Cohen, MD No disclosure on file
Nahum Nesher (Tel Aviv Medical Center) Steve Barash has received personal compensation for serving as an employee of Teva. Steve Barash has received stock or an ownership interest from Teva.
Verena *use 212969 Ramirez Campos (Teva Pharmaceuticals) Verena Ramirez Campos has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center) Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alergan. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Davies McFarland & Carroll, LLC. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for SHEEHEY FURLONG & BEHM P.C.. The institution of Dr. Silberstein has received research support from Lundbeck. The institution of Dr. Silberstein has received research support from abbvie. The institution of Dr. Silberstein has received research support from lundbeck. Dr. Silberstein has received publishing royalties from a publication relating to health care.